Amaranth Medical highlights 9-month follow-up data for Aptitude sirolimus-eluting bioresorbable scaffold
Amaranth Medical touted 9-month follow-up data today from the Renascent-II trial, which evaluated the company’s Aptitude sirolimus-eluting bioresorbable scaffold.
Aptitude is a poly-L-lactide-based, sirolimus-eluting bioresorbable scaffold that features a strut thickness of 115 microns. The 60-patient trial had a 98.3% device success rate, high scaffold stability and a 97% level of strut coverage at 9 months.
The company also said that no instances of thrombosis or binary restenosis were reported in this patient population.
Amaranth submitted an application for CE Mark approval of its Aptitude scaffold in the December last year and said that it expects to win approval in the 2nd half of 2017. Based on data from the Renascent-II trial, the company plans to start discussions with partners and sources of financing to continue developing its tech for coronary, peripheral and neurological indications.
Amaranth added that it is planning initial commercial preparations for the 1st sub-100 micron bioresorbable scaffold, Magnitude.
“The BRS field is navigating turbulent waters right now; however, I continue to believe that complete scaffold absorption brings additional value to the patient by decreasing progressive late lumen loss and expanding the re-intervention options in comparison to metallic DES,” co-principal investigator Juan Granada said in prepared remarks. “The technical and clinical performance of the thin-walled Aptitude BRS has been successfully evaluated in a multi-center clinical trial. I am looking forward to seeing this device used in real-world cases.”
“Clinical outcomes at 9-months for the patients in the Renascent-II trial have been excellent, displaying a safety and efficacy profile compared to metallic DES. We hope that long-term data continue to confirm the structural stability and safety of the device and add momentum to the field again,” co-principal investigator Dr. Antonio Colombo added.
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